Senior Supplier Quality Engineer - CST - Lafayette, CO (Onsite)
Medtronic · Lafayette, Colorado, United States of America
Job description
We anticipate the application window for this opening will close on - 12 Jul 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the LifeAs one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across the globe. Check us out on LinkedIn: Medtronic CST Job Description: As a Senior Supplier Quality Engineer, you will play a key role in ensuring the quality, reliability, and long-term stability of supplier-provided materials, components, and services that support new product launches. In this role, you will provide supplier quality support for Regional Expansions, Design Changes, and Supplier Development initiatives, partnering cross-functionally to ensure successful product commercialization and sustained supplier performance. You will lead supplier qualification and development activities, execute risk-based quality strategies, assess supplier performance, and drive compliance with applicable quality and regulatory requirements while fostering continuous improvement across the supply base. Key Responsibilities: Lead supplier quality initiatives to ensure suppliers consistently deliver high-quality materials, components, and services that meet Medtronic's quality, regulatory, and business requirements. Drive supplier qualification, selection, and approval activities, supporting supplier certification programs and strategic supplier development initiatives that enhance quality, reliability, and cost-effectiveness. Monitor and evaluate supplier performance across the product lifecycle, proactively identifying, communicating, and resolving supplier quality issues while driving sustainable corrective and preventive actions. Develop, prioritize, and execute risk-based supplier audit plans to ensure compliance with Good Manufacturing Practices (GMP), quality management systems, and global regulatory requirements. Assess supplier quality systems, manufacturing processes, technical capabilities, and operational performance, providing leadership and guidance to drive continuous improvement and long-term supplier stability. Serve as the Supplier Quality Engineering lead for New Product Development (NPD) programs, supporting Regional Expansions, Design Changes, and Supplier Development initiatives to ensure successful product launches and robust supplier readiness. Partner closely with Component Engineering, R&D, Manufacturing, Sourcing, and Post-Market Supplier Quality teams to establish supplier quality strategies, ensure effective supplier selection and qualification, and drive compliance throughout the product development lifecycle. Lead quality planning activities for purchased materials and components, ensuring compliance with applicable industry standards, regulatory requirements, and customer expectations while supporting design transfer and commercialization. Collaborate with Component Engineers to develop product acceptance sampling strategies, manage Approved Supplier List (ASL) activities, implement Supplier-Owned Quality (SOQ) programs, and establish effective control plans for new products. Define Receiving Inspection requirements, support validation of internal test methods, and ensure robust verification processes for supplier-provided components and materials. Drive defect prevention, risk mitigation, supplier capability improvement, and process optimization initiatives that strengthen supplier performance and ensure the delivery of safe, reliable, and high-quality medical devices. Location: Lafayette, CO (Onsite) Onsite: At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This role will require <10% of travel to enhance collaboration and ensure successful completion of projects. Minimum requirement: Bachelors degree in Engineering or Technical field with minimum of 4 years of relevant experience, OR Advance degree in Engineering or Technical field with minimum of 2 years of relevant experience Nice to Have (Preferred Qualifications): Experience supporting supplier qualification, supplier audits, supplier development, and supplier performance management within a regulated industry. Knowledge of quality management systems and applicable regulatory requirements, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP). Experience supporting New Product Development (NPD) activities, including Design Controls, risk management, process validation, and control plan development. Proficiency in quality engineering tools and methodologies, including CAPA, root cause analysis, statistical techniques, FMEA, and continuous improvement practices. Experience conducting supplier assessments and audits, with the ability to evaluate supplier quality systems and drive corrective actions. ASQ certification (CQE, CSQP) and/or Lean Six Sigma Green Belt or Black Belt certification preferred. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the foll
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